Zogenix plans to resubmit a New Drug Application for Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome.
Myovant is preparing to seek regulatory approval for the company’s once-daily relugolix combination therapy for the treatment of uterine fibroids following positive Phase III results that showed a 71.2 percent response rate in patients.
GlaxoSmithKline, Pfizer and Shinogi’s joint venture ViiV Healthcare said the Phase III BRIGHTE study hit 96-week endpoints in heavily treatment-experienced adults with HIV-1 infection.
Acadia Pharmaceuticals Inc.’s add-on treatment pimavanserin for schizophrenia failed to meet the main goal in a late-stage study.
Shares of Israel-based Intec Pharma Ltd. were down nearly 82 percent after the company announced that the Phase III Parkinson’s disease therapy Accordion Pill failed to demonstrate statistical superiority to treatment with Sinemet, a combination of carbidopa and levodopa.
GlaxoSmithKline Plc’s cancer treatment Zejula met the main goal of helping patients with ovarian cancer live longer without their disease worsening in a late-stage study, the company said.
Novartis, Amgen and the Banner Alzheimer’s Institute announced they are halting two pivotal Phase II/III clinical trials in the Alzheimer’s Prevention Initiative Generation Program.
A new discovery at the Feinstein Institutes for Medical Research could have implications in the way diabetes is treated in the future.
Research from three clinical trials supports that Sarepta Therapeutics’ Exondys 51 slows respiratory decline in DMD.
GlaxoSmithKline Plc’s two-drug HIV regimen Dovato was successful in suppressing the AIDS-causing virus in patients over 48 weeks at the same level of a previous three-drug treatment in a late-stage trial.
